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 Case Digest

Drugs and Cosmetics Rules, 1945
Rule 65 (15) (c)—Qualified Person—meaning of
Rule 65 (15) (c)—Qualified Person—meaning of
Provisions – not violative of Article 19 (1) (g) of the constitution - apart from a drug contained in a container in which the manufacturer has marketed it, on other drug can be supplied or sold by a retail dealer except by or under the supervision of a “qualified person”—a retail dealer is prohibited from supplying any drug on the prescription of a registered medical practitioner unless he is a “qualified person” or he is supplying the drug under the supervision of a “qualified person”—sub-rule (19) 0f rule 65 does not exclude the supply in retail of any drug in an envelope or in other suitable wrapper or container etc. by a person who himself is a “qualified person”. There is no conflict between sub-rule (2) and sub-rule (19) of rule 65. Sub-rule (2) emphasise that there can be no compounding or the manufacture of any drug or the making of a drug except under direct and personal supervision of a “qualified person”. It also emphasise that in the case of a retail dealer any drug supplied on the prescription of a registered medical practitioner shall be effected only under the direct supervision of a “qualified person” whereas sub-rule (19) does not talk of the supply of a drug on the prescription of a registered medical practitioner.
M/s. J. Das Brothers and others vs. Union of India and others, Allahabad High Court, 1992 Drugs Cases (DC) 302


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